We have a vacancy for a Clinical Science Lead
Blueberry’s vision is to bring high value, innovative medicines to the market that make a real difference to patients’ lives. We are now growing, and looking for a full time Clinical Science Lead t to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.
To recruitment companies: ALL unsolicited emails, phone calls or CVs will not be acknowledged.
Clinical Science Lead
The Clinical Science Lead (CSL) has overall responsibility for clinical trial design and pipeline implementation including providing clinical scientific expertise, clinical strategy, implementation of the Product Development Plan (PDP), as well as participation in problem-solving initiatives within development projects.
He or she will work under limited supervision to develop solutions utilising creativity and ingenuity, represent the organisation as a prime contact for clinical scientific matters and manage responsibility under a no-cost centre budget. The CSL will also provide cover and back up for the Clinical Operations Lead (COL).
Main Roles & Responsibilities
- Working with the broader Blueberry team, have overall responsibility for producing the PDP from nonclinical handover through to market approval across phase I-IV, according to Blueberry objectives.
- Deliver clinical trial phase I-IV protocols, trial designs, endpoint identification in conjunction with statistical/subject matter experts and in collaboration with Clinical Operations.
- Collaborate with Clinical Operations and Finance to plan and track expenditure of PDP whilst maintaining sensitivity to overall company budget.
- Support Clinical Operations in the execution of clinical trials and supporting activities (e.g. author/review essential documents and submission packages).
- Work with the nonclinical Research teams to help develop nonclinical strategies for the development of compounds.
- Overall responsibility for the review and interpretation of clinical trial data and results. Aid in the development of headline result presentations and publications for the Executive team and public domain.
- Maintain therapeutic area expertise to lead interactions with external subject matter experts, Regulatory Authorities etc. at Scientific Advice meetings, Advisory Boards, Investigator Meetings, Conferences etc. as required.
- May attend and/or present to Executive team meetings, delivering clinical scientific landscape and competitor updates as required.
- Collaborate with Clinical Operations in risk management activities.
- Collaborate with Clinical Operations to manage and improve Quality Management systems, tools and documents (e.g. SOPs, guidelines and training), technologies and outsourcing needs.
- Collaborate with Clinical Operations to maintain oversight of CROs, vendors and consultants to ensure completion of assigned project work according to agreed scope, quality, budget and timelines. This may include troubleshooting routine client inquiries.
- Train and mentor Clinical and vendor team members and support the training of other staff (e.g. Finance, Nonclinical) as required, sharing knowledge, experiences and best practice.
- Provide input into non-project work and development of procedures.
- Have an easily discernible impact on the job area and expected results
- Degree in relevant scientific subject e.g., biochemistry, pharmacology.
- Minimum 10+ years’ industry experience in Clinical, Regulatory or Medical functional areas and at a Program level for some of that time
- Up to date GCP training (within last 2 years)
- Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
- Strong team player
To apply for this role, please email your CV and covering letter to Susie Yau, Office Manager: firstname.lastname@example.org by Friday 27th September 2019.